Ongoing Clinical Trials for Hyponatraemia
Currently, there are 3 ongoing clinical trials investigating new treatment approaches for patients with hyponatraemia, a condition characterized by abnormally low sodium levels in the blood. These trials are testing different medications including DDAVP, empagliflozin, and urea, and are being conducted across France, Germany, and the Netherlands.
Clinical trial locations
- France
- Germany
- Netherlands
Study on Using Desmopressin Acetate Trihydrate to Prevent Sodium Overcorrection in Patients with Severe Hyponatremia
This trial is investigating the use of DDAVP (desmopressin acetate trihydrate) to prevent a dangerous complication that can occur when treating severe low sodium levels in the blood. While it is important to raise sodium levels in patients with severe hyponatraemia, doing so too quickly can lead to serious brain damage. This study aims to determine whether DDAVP can help control how fast sodium levels rise during the first 48 hours of treatment.
Who can participate: This study is recruiting adults aged 18 years or older who are currently admitted to an intensive care unit with severe hyponatraemia. Eligible participants must have sodium levels below 120 mmol/L along with neurological symptoms such as seizures, near-unconsciousness with a Glasgow Coma Scale score less than 12, or signs of brain herniation. Alternatively, patients with sodium levels below 115 mmol/L without these symptoms may also qualify. Participants must have normal or decreased fluid levels outside their cells.
Who cannot participate: Patients who are at high risk of having their sodium levels corrected too rapidly are excluded from this study, as the rapid increase in sodium can be particularly dangerous for these individuals.
Study focus: The trial will monitor participants closely in the ICU setting, where they will receive either DDAVP or a placebo along with standard treatments. Researchers will track sodium levels, neurological symptoms, length of hospital stay, and any potential side effects. The study will also use other substances like sodium chloride, potassium chloride, and glucose solutions to help manage fluid and electrolyte balance.
Investigational drug: DDAVP works by mimicking a hormone called vasopressin, which helps regulate water balance in the body. By controlling how much water is removed from the body, DDAVP helps stabilize sodium levels and prevents them from rising too quickly.
Study on the Effects of Empagliflozin in Patients with Euvolemic and Hypervolemic Hyponatremia
This clinical trial is exploring whether empagliflozin (brand name Jardiance), a medication typically used to help control blood sugar levels in people with diabetes, can help raise sodium levels in patients with chronic hyponatraemia. The study will examine whether taking empagliflozin once daily can lead to a greater increase in blood sodium levels over 4 days and 30 days compared to a placebo.
Who can participate: This study is open to men and women aged 18 years or older who have chronic euvolemic or hypervolemic hyponatraemia. This means having low sodium levels not caused by dehydration or high blood sugar. Participants must have sodium levels below 135 mmol/L on the day they join the study. Participants should be able to make decisions for themselves and not be in vulnerable situations.
Who cannot participate: Patients with certain forms of hyponatraemia, those outside the specified age range, and members of vulnerable populations such as children, pregnant women, or those unable to give consent cannot participate.
Study focus: This double-blind study will randomly assign participants to receive either empagliflozin or a placebo. Neither participants nor researchers will know who receives the actual medication to ensure unbiased results. Throughout the study, sodium levels will be monitored regularly. Researchers will also assess changes in overall well-being, quality of life, and symptoms such as headache, dizziness, and nausea. Other health indicators including blood pressure, heart rate, and body weight will be tracked. Patients will have assessments on days 0, 4, and 30, with a follow-up around day 37.
Investigational drug: Empagliflozin is an SGLT2 inhibitor that helps the kidneys remove excess sugar from the body through urine. This can also lead to changes in fluid balance and sodium levels. The study aims to determine whether this mechanism can effectively correct low sodium levels in patients who retain too much water.
Study on Urea for Treating Low Sodium Levels in Patients with Brain Hemorrhage
This trial is testing whether urea, administered as an oral powder, can effectively treat low sodium levels that occur during a subarachnoid hemorrhage. A subarachnoid hemorrhage is a type of stroke caused by bleeding on the surface of the brain. The study aims to demonstrate whether urea can correct persistent hyponatraemia even when other management strategies have been adequately applied.
Who can participate: This study is recruiting men and women aged 18 years or older who have experienced a non-traumatic subarachnoid hemorrhage and have developed hyponatraemia with sodium levels below 135 mmol/L. Participants must also have high sodium levels in their urine (greater than 250 mmol per day) despite well-managed salt intake.
Who cannot participate: Patients whose low sodium levels are not persistent despite adequate management, those outside the specified age range, and members of vulnerable population groups are not eligible to participate.
Study focus: Participants will receive either urea or a placebo for a treatment period lasting up to five days. The study will monitor changes in sodium levels before and after treatment, assessing how much sodium intake is needed to correct the levels and how urea works in the body. Researchers will track how quickly sodium levels are corrected and whether the correction persists 48 hours after stopping treatment. The study will also evaluate the impact on hospital stay length and neurological outcomes three months after starting treatment, along with any potential side effects.
Investigational drug: Urea works as an osmotic diuretic, meaning it helps the body remove excess water by increasing urine production. By increasing the concentration of solutes in the blood, urea draws water out of cells and into the bloodstream, thereby increasing sodium concentration. This mechanism aims to restore normal sodium levels in patients with this specific type of brain hemorrhage.
Summary
These three clinical trials represent different approaches to managing hyponatraemia in various clinical settings. Two of the trials are being conducted in France, focusing on severe cases in intensive care and those related to brain hemorrhage. The third trial is taking place in both Germany and the Netherlands, investigating a diabetes medication for chronic forms of the condition.
The studies test three distinct medications with different mechanisms of action: DDAVP prevents overcorrection of sodium levels, empagliflozin uses kidney-based mechanisms to adjust fluid and sodium balance, and urea works as an osmotic diuretic. Each trial targets specific patient populations, from those in intensive care with severe symptoms to patients with chronic conditions or those recovering from brain hemorrhage.
Together, these trials aim to improve understanding of how to safely and effectively manage low sodium levels, a condition that can lead to serious complications if not properly treated. The research may lead to better treatment options for patients experiencing this potentially dangerous electrolyte imbalance.
